MAUDE Adverse Event Report: COOK INC BAKRI TAMPONADE BALLOON CATHETER; KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC

Model Number N/A

Device Problem Material Rupture (1546)

Patient Problem Blood Loss (2597)

Event Date 04/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

It was reported that bakri tamponade balloon catheter ruptured during an intended procedure to treat postpartum hemorrhage cesarean section on a female patient.The balloon ruptured after the physician injected 350 ml saline solution.The physician replaced the device with a new bakri tamponade balloon catheter but the hemorrhage did not stop.No unintended section of the device remained inside the patient¿s body.The physician resected the patient's uterus to complete the procedure.It was further reported that the patient¿s condition was stable post-surgery.

Manufacturer Narrative

Investigation ¿ evaluation: as anticipated, the bakri tamponade balloon catheter was not returned for evaluation.No photos have been provided.Without the complaint device, a physical investigation was not able to be completed.There is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.The device history record was reviewed and no non-conformances were noted.A review of complaint history for this product/lot number combination revealed this is the only complaint associated with complaint lot number 7434910.Based on the provided information and the investigation evaluation the likely root cause is related to product use or handling and/or caused by another device.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: BAKRI TAMPONADE BALLOON CATHETER
• Type of Device: KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6553445
• MDR Text Key: 74704770
• Report Number: 1820334-2017-00834
• Device Sequence Number: 1
• Product Code: KNA
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)191110(10)7434910
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K062438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: J-SOS-100500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/17/2017
• Initial Date FDA Received: 05/09/2017
• Supplement Dates Manufacturer Received: 09/19/2017
• Supplement Dates FDA Received: 09/28/2017
• Date Device Manufactured: 11/10/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Weight: 56